Table 3.
Reproductive outcomes for women in Ding-Kun Pill and placebo groups (intention-to-treat analysis).
| Outcomes | Ding-Kun Pill group (n = 231) | Placebo group (n = 231) | Relative risk (95% CI) | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| Ongoing pregnancy * | ||||
| Ongoing pregnancy rate/No. of randomised women | 61/231 (26.4) | 56/231 (24.2) | 1.09 (0.80 to 1.49) | 0.593 |
| Ongoing pregnancy rate/No. of women who started stimulation | 61/225 (27.1) | 55/228 (24.1) | 1.12 (0.82 to 1.54) | 0.466 |
| Ongoing pregnancy rate/No. of oocyte retrievals | 61/225 (27.1) | 55/225 (24.4) | 1.11 (0.81 to 1.52) | 0.518 |
| Ongoing pregnancy rate/No. of embryo transfers | 61/206 (29.6) | 55/209 (26.3) | 1.13 (0.83 to 1.53) | 0.454 |
| Secondary outcomes | ||||
| Clinical pregnancy | ||||
| Clinical pregnancy rate/No. of randomised women | 77/231 (33.3) | 70/231 (30.3) | 1.10 (0.84 to 1.44) | 0.484 |
| Clinical pregnancy rate/No. of women who started stimulation | 77/225 (34.2) | 69/228 (30.3) | 1.13 (0.87 to 1.48) | 0.367 |
| Clinical pregnancy rate/No. of oocyte retrievals | 77/225 (34.2) | 69/225 (30.7) | 1.12 (0.85 to 1.46) | 0.421 |
| Clinical pregnancy rate/No. of embryo transfers | 77/206 (37.4) | 69/209 (33.0) | 1.21 (0.81 to 1.81) | 0.352 |
| Positive pregnancy † | ||||
| Positive pregnancy rate/No. of randomised women | 85/231 (36.8) | 82/231 (35.5) | 1.04 (0.81 to 1.32) | 0.771 |
| Positive pregnancy rate/No. of women who started stimulation | 85/225 (37.8) | 81/228 (35.5) | 1.06 (0.84 to 1.36) | 0.619 |
| Positive pregnancy rate/No. of oocyte retrievals | 85/225 (37.7) | 81/225 (36.0) | 1.05 (0.74 to 1.58) | 0.696 |
| Positive pregnancy rate/No. of embryo transfers | 85/206 (41.3) | 81/209 (38.8) | 1.07 (0.84 to 1.35) | 0.602 |
| Pregnancy loss rate ‡ | 38/85 (44.7) | 36/82 (43.9) | 1.02 (0.73 to 1.43) | 0.917 |
| Pregnancy loss ≤12 weeks of gestation | 37/85 (43.5) | 34/82 (41.5) | 1.05 (0.74 to 1.50) | 0.787 |
| Pregnancy loss >12 weeks of gestation | 1/85 (1.2) | 2/82 (2.4) | 0.48 (0.05 to 5.22) | 0.616 |
| Ectopic pregnancies ‡ | 0/85 (0) | 1/82 (1.2) | – | 0.491 |
Embryo implantation rate (median (IQR)) 
|
0 (0.5) | 0 (0.5) | – | 0.500 |
| Twin pregnancies | 5/77 (6.5) | 11/70 (15.7) | 0.41 (0.15 to 1.13) | 0.073 |
All analyses by intention to treat.
*Ongoing pregnancy was defined as a detectable fetal heart beat after 20 weeks of gestation.
†Positive pregnancy (biochemical pregnancy), i.e. serum β-hCG level ≥10 mIU/ml.
‡Denominator defined as number of positive β-hCG values (≥10 IU/ml) in each group.
Embryo implantation rate was defined as the number of intrauterine gestational sacs observed divided by the number of embryos transferred.
Data are number/total number (%) of women unless stated otherwise.